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St. Jude Defibrillators

Truth: The St. Jude defibrillators are meant to prevent irregular heartbeats by regularly administering electrical shocks to a patient’s heart whenever it detected an irregular heartbeat.

Truth: Instead, the battery would prematurely drain, risking the lives of the patients they were supposed to save.

Truth: The FDA ordered a recall of all St. Jude’s Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators in 2016 due to these battery issues.

Patients with heart arrhythmias, including slow, fast, or irregular heartbeats, relied on defibrillator devices such as those made by St. Jude’s to prevent dangerous and life-threatening cardiac events. The device batteries would short circuit and drain prematurely, causing the devices to fail. A patient wouldn’t know until it was too late that the device’s battery had failed prematurely and could, therefore, experience life-threatening cardiac events or even death.

The FDA found that St. Jude had known about the defibrillators’ battery issues, yet hadn’t acted to protect patient health. Instead, the company had continued to sell the device until the FDA discovered the battery failures and ordered a recall.

If you or a loved one has been affected by the failure of a St. Jude defibrillator, don’t wait to get the justice you deserve. We’ll fight for you against the company that chose profit over people’s health and get you the compensation you need. Contact us now for a free consultation. You pay nothing unless your case is successful.

What Is Defibrillation?

Defibrillation is a medical treatment that is used to treat cardiac arrhythmias by sending electrical currents into the heart in an attempt to restore a normal rhythm. Defibrillation is used in emergency treatment for life-threatening cardiac events but is also a longer-term treatment for patients with slower-than-normal heartbeats.

What Are Heart Arrhythmias?

Heart arrhythmias are any cardiac event that involves a heartbeat that isn’t at a normal rhythm. Also called dysrhythmias, or just irregular heartbeats, there are a variety of arrhythmias, but they fall into several main categories, including:

    • Tachycardia (the heartbeat is too fast)
    • Bradycardia (the heartbeat is too slow)
  • Irregular heartbeat
  • Extra heartbeats

Heart Arrhythmias

Less severe arrhythmias can often be treated with medication, including beta blockers, blood thinners, and procainamide. Other treatments are pacemakers and surgery. More severe arrhythmias are treated with electric shocks by either cardioversion or defibrillation.

Symptoms of Heart Arrhythmias

Many types of arrhythmias aren’t serious and often don’t have any symptoms at all. In more minor arrhythmias, symptoms may include feeling a pause between heartbeats, or heart palpitations.

More serious forms of arrhythmias will have more serious symptoms, including:

  • Chest pain
  • Shortness of breath
  • Lightheadedness
  • Loss of consciousness

Any arrhythmia can predispose someone to more serious medical conditions if left untreated, including:

  • Stroke
  • Heart failure
  • Cardiac arrest
  • Brain damage
  • Death

Symptoms of Heart Arrhythmias

How Do Defibrillators Work?

Defibrillation isn’t like in movies and on TV, where it’s used to restart a stopped heart. In fact, defibrillators actually stop the heart using an electrical current in order to interrupt the irregular heartbeat. Defibrillation depolarizes the heart and interrupts the heart’s electrical conduction system so that it can restart at a normal rhythm.

Types of Defibrillators

Manual Defibrillators

There are both internal and external kinds of manual defibrillators. The manual internal ones are most often used in operating rooms, while the manual external defibrillators are in hospitals and ambulances. Both kinds require trained medical professionals to operate because they require the diagnosis of the cardiac arrhythmia and a calculation for timing and voltage of the electric shock.

Automatic External Defibrillators

AEDs, or automatic external defibrillators, are portable automatic defibrillators that are used by first responders and in first aid and CPR as a basic life support treatment. They’re used primarily to treat ventricular tachycardia (a heartbeat that is regular but too fast) and ventricular fibrillation (when the heart quivers instead of pumping blood). Both conditions are caused by irregular electrical activity in the heart’s ventricles (the large chambers of the heart).

There’s also an automatic internal defibrillator that’s used in heart bypass surgeries.

Implantable Cardioverter-Defibrillators

There are two kinds of cardioverter-defibrillators: implantable and wearable. The wearable defibrillator is used with at-risk patients who aren’t able to have an implantable cardioverter-defibrillator. The automatic implantable cardioverter-defibrillator, or AICD, is implanted into patients similarly to pacemakers.

They monitor the patient’s heartbeat constantly and deliver an electrical shock as needed to treat any form of heart arrhythmia. They can be programmed differently for each patient’s individual condition.

Risks of Implantable Cardioverter-Defibrillators

The risk of having an implantable cardioverter-defibrillator is that there is a chance the device can misfire inappropriately. Especially if the misfires are constant, this can be considered a medical emergency. Not only does it deplete the device’s battery, but it is also extremely uncomfortable and anxiety-inducing for the patient and can even cause the very heart arrhythmias it’s supposed to prevent.

Risks of the Implantation Surgery

Any surgery has some risks involved. For the surgery to implant a defibrillator, the risks include:

  • Bleeding
  • Infection
  • Pneumothorax (collapsed lung)
  • Damage to the heart
  • Damage to blood vessels

Risks of Using an ICD

The biggest risk of using an implanted cardioverter-defibrillator is usually inappropriate shocks, which are shocks that the device gives even when there’s not cardiac event to warrant the shock. The device is supposed to monitor the specific condition of the patient and is programmed to respond whenever the patient’s heartbeat is irregular, or too fast or too slow, but inappropriate shocks occur from time to time.

An inappropriate shock, while painful, is not usually dangerous to a patient and can be caused by any faster heartbeats, even those caused by exercise. Constant inappropriate shocks can drain the battery, risking the patient’s life if a cardiac event occurs, or can even cause the event. In most cases, unless the device was defective, it may just need to be reprogrammed by the doctor.

St. Jude’s Defibrillator

Both St. Jude’s Implantable Cardioverter Defibrillator and the Cardiac Resynchronization Therapy Defibrillator were devices implanted into the skin of a patient’s upper chest that had wires that connected to the heart. These devices were designed to provide pacing and electrical shocks for tachycardia and bradycardia, or for heartbeats that otherwise needed coordination.

FDA Recall

These St. Jude defibrillators, which were sold from 2010 to 2016, were recalled by the FDA in a Class I recall, the FDA’s most serious recall, in 2016 because their batteries would deplete prematurely. This was caused by lithium deposits that would build up in the batteries, short-circuiting them. For patients who relied on these devices to prevent life-threatening cardiac events, this was extremely dangerous, because the battery could run down and fail to provide the necessary pacing or electrical shocks the patient needed. The patient wouldn’t know of the issue, which could lead to their death, until it was too late.

FDA Investigation

The FDA found in 2017 that St. Jude had been aware for many years of the problems with the lithium batteries in their defibrillators, but had continued to sell them for several years before finally recalling them at the order of the FDA in 2016. St. Jude, which was acquired by Abbott in January of 2017, hadn’t shown the FDA that it had taken sufficient steps to address the issue. There was a delay in the recall, understating the severity of the problem, failures to communicate the issues with the battery to the company’s medical board and management, and the faulty devices were found to have caused at least two deaths. After these findings, the FDA ordered St. Jude Medical to provide a new plan of action within 15 days.

St. Jude’s Failure to Recall

St. Jude had discovered the problem with the batteries as early as 2014 after reports of failures from doctors at the University of Illinois and Duke University. Both universities found the same issue with the defibrillators: that the lithium in the battery clustered and short-circuited the device. The company addressed the problem in newer devices but failed to recall the older ones that could have had the battery problem.

The company also did not alert doctors or patients to the issue until they finally recalled the device in October of 2016. This resulted in doctors continuing to implant the St. Jude defibrillators into patients for several years after the problem was discovered.

FDA Recommendations

After the recall of the St. Jude defibrillators was ordered, the FDA recommended to doctors that they closely monitor any patient who had one implanted. This was because the surgery to remove and replace the device is risky for patients. The FDA considered it best to replace devices on a patient-by-patient basis rather than unnecessarily risk patients if their particular device wasn’t one of those affected by the lithium battery issues.

Litigation Against St. Jude

Since the recall of their defibrillator devices, St. Jude and its parent company, Abbott, have been subject to litigation over their failure to recall the devices earlier and for their failure to warn doctors and patients of the risks of using the devices. A class-action lawsuit against the companies was filed in Chicago in 2017, alleging that the companies failed to properly investigate and report the issues with the lithium batteries.

The defibrillator devices that were addressed in the lawsuit include:

  • Fortify
  • Fortify Assura
  • Quadra Assura
  • Unify
  • Unify Assura
  • Unify Quadra

Because part of the lawsuit alleged that the health costs of the device failures had fallen on the patients, the public, and insurance companies, St. Jude reportedly agreed to pay out-of-pocket for those expenses.

St. Jude was also subject to litigation from the Muddy Waters Capital investment firm, who claimed that the defibrillator devices were hackable and could be the targets of cyber attacks that would cause inappropriate shocks to patients. St. Jude denied those allegations.

When Should I Consider a St. Jude Defibrillator Lawsuit?

Has your St. Jude defibrillator short-circuited as a result of the lithium battery issue? Did this cause health problems or discomfort? Was your life, or the life of a loved one at risk? Did a loved one die as a result of the defibrillator failure?

If you have answered yes to any of the above questions, you may have a case against St. Jude Medical and Abbott for the battery failures in their implantable defibrillator devices. Contact Farah & Farah now to speak with one of our highly experienced lawyers. We’re experts in the medical lawsuit field and want to help you get the compensation you deserve. When companies choose profit over patients’ lives, we’re there to pursue justice on your behalf. The consultation is free and you won’t pay a dime unless your case is successful.

Co-counsel will be associated on these cases.